VYXEOS preparation and administration
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Download PDFEquilibrate the appropriate number of vials of VYXEOS to room temperature for 30 minutes.
Steps for preparing VYXEOS1
VYXEOS is a cytotoxic drug. Follow applicable special handling and disposal procedures1
Reconstitute and further dilute VYXEOS prior to intravenous infusion1
Reconstitute each vial with 19 mL of Sterile Water for Injection using a sterile syringe
- Carefully swirl the contents of the vial for 5 minutes while gently inverting the vial every 30 seconds
- Do not heat, vortex, or shake vigorously
After reconstitution, let rest for 15 minutes
- The reconstituted product should be an opaque, purple, homogeneous dispersion, essentially free from visible particulates
- After reconstitution but before final dilution, each mL of VYXEOS will contain 2.2 mg of daunorubicin and 5 mg of cytarabine
Use the reconstituted solution immediately. If needed, store the reconstituted solution in the vial refrigerated at 2°C to 8°C (36°F to 46°F) for up to 4 hours. Note that the reconstituted product in the vial and the reconstituted product which has been diluted into an infusion solution are stable for a total of 4 hours (not 4 hours each) when stored at 2°C to 8°C
Gently invert each vial 5 times and aseptically withdraw the calculated volume of reconstituted product from the vial(s) using a sterile syringe
Transfer the calculated volume to an infusion bag containing 500 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP
- Discard any unused portion or residual product remaining in the vial and do not save any unused portions for later administration
Gently invert the bag to mix the solution
- The dilution of the reconstituted product results in a deep purple, transluscent, homogenous dispersion, free from visible particulates
- Only solutions without visible particulates should be used
If the diluted infusion solution is not used immediately, store in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 4 hours. If the reconstituted solution in the vial was stored for 4 hours, the diluted infusion solution must be used immediately and cannot be stored for an additional 4 hours
Please see the VYXEOS Prescribing Information for the full preparation and handling instructions.